Brexit compliance, application of the EU MDR, and upcoming IVDR deadline, Europe is the busiest region with evolving Regulatory landscape. All these timelines have kept the Regulatory professional on their toes. Post-Brexit, the first MHRA grace period for active implantable medical devices, Class III, Class IIb implantables, and IVD list A devices ended on April 30, 2021, and the second MHRA grace period for Class IIb non-implantables, Class IIa medical devices concluded on August 31, 2021. Now, the medical device industry is moving towards the third MHRA grace period due on December 31, 2021.
While the device manufacturers are exploring available options to appoint a UKRP, it is crucial to understand the significance of this role and what it takes an entity or individual to act as a UKRP. This article throws light on why having the right set of experiences is important to act as a UKRP. Post to Brexit and the release of new regulations & guidelines by the UK MHRA, there has been incredible demand in UKRP Services. Many individuals with a local presence in the UK have started claiming to act as a UKRP, and many companies have been blooming since then. These companies without experience are here only to make revenue out of the Regulatory requirements set by the UK MHRA and do not provide Regulatory compliance or customer satisfaction.
When the UK MHRA made it mandatory for the non-UK manufacturers to appoint a UKRP post-Brexit, many small and new organizations, including pseudo companies, started blooming in the UK, seeing huge market potential. Many existing companies in the UK got themselves registered as a UKRP and started to act as UKRP. However, some companies are offering UKRP services without substantial prior experience on MHRA Regulatory compliance, there exists a fair possibility of them being unable to fulfil all the roles and responsibilities of UKRP set by the UK MHRA. Also consider that many such UKRP service providers offer much cheaper rates than standard, as a measure to attract manufacturers. Device manufacturers are advised to not approach such heavily discounted UKRP service providers.
The United Kingdom left the European Union in the initial months of 2020 and went under an 11-month transition period. On January 1, 2021, Brexit came into full force. Post-Brexit, there were many changes that the UK went through, especially in the area of Medical Devices and IVD products.
The Brexit has been in effect from January 01, 2021, impacting every bilateral aspect between the European Union (EU) and the United Kingdom (UK). There have been new regulations in place for the citizens as well as the stakeholders from various industries. The new medical device regulations released by the UK MHRA also have come into effect from January 01, 2021. The UK MHRA had provided certain extended grace periods for different device classes based on the risk and their registrations.
Post the Brexit implementation, most of the Medical Device Industry stakeholders have been busy chalking their plans towards complying with new requirements and new UK MDR 2002 regulations. One critical need for the non-UK device manufacturers, who intend to market their products in the UK, is to appoint a UKRP. Manufacturers may either choose to appoint a reliable UKRP service provider or their importer/distributor to represent their device in the UK market. The manufacturer may wonder what questions they should ask their potential UKRP to evaluate their expertise and experience with the MHRA and the UK Medical Device regulations. Here is the list of top 10 questions a medical device manufacturer can ask their UKRP service provider -
Exit of the United Kingdom from the European Union has implications on the medical device and IVD industry. The post-Brexit medical device regulations released by the UK MHRA mandated that all the foreign medical devices and IVD companies to appoint a United Kingdom Responsible Person (UKRP) to act on their behalf.
As a result of the UK MHRA mandate, starting from January 01, 2021, the manufacturers have already been appointing the UK Responsible Person as per the four (04) months, eight (08) months and 12 months’ transition timelines for various device categories. Though appointing a UK Responsible Person sounds like a one-time activity, there are various aspects to be taken care from time to time post the appointment.
United Kingdom Responsible Person (UKRP) plays a major role in representing a non-UK manufacturer and their medical device product with the Medicines and Healthcare Products Regulatory Agency (MHRA). The UKRP, who is responsible for registration of devices with the MHRA, shall: